Navigation Links
VIVUS Initiates Open Label Safety Study of Avanafil for Erectile Dysfunction

Enrollment in First Pivotal Phase 3 Avanafil Study REVIVE (TA-301) is Complete

MOUNTAIN VIEW, Calif., May 13 /PRNewswire-FirstCall/ -- VIVUS, Inc. (Nasdaq: VVUS), a biopharmaceutical company developing innovative, next-generation therapies to address unmet needs in obesity, diabetes and sexual health, today announced that it has initiated an open label safety study (TA-314) with its investigational drug, avanafil, in males with erectile dysfunction (ED).

VIVUS also announced today that it has completed enrollment in REVIVE (TA-301), a randomized, double-blind, placebo-controlled phase 3 study of avanafil in men with a history of generalized ED and the first of several planned phase 3 studies of avanafil. Approximately 650 patients have been enrolled in the study. Top-line results of REVIVE are expected in the fourth quarter of 2009.

Avanafil, a next-generation, fast-acting, selective, oral, phosphodiesterase type 5 (PDE5) inhibitor, is VIVUS' investigational product for the treatment of ED. The phase 3 program for avanafil is funded through a $30 million collaboration with Deerfield Management.

"We continue to make excellent progress on the avanafil phase 3 program, and are pleased with the rapid rate at which we accrued patients in our first pivotal study, REVIVE," commented Charles Bowden, MD, senior director of clinical development at VIVUS. "Initiation of the TA-314 safety study is a critical step in advancing avanafil toward an NDA filing. We are confident that avanafil will provide a much needed new option for the millions of men living with ED, and we look forward to announcing data from both of these studies later this year and next."

The open-label study is being conducted in approximately 600 patients across 40 U.S. centers. Patients completing either the 12-week REVIVE or REVIVE-Diabetes studies are eligible to participate in TA-314. The goal of the TA-314 study is to collect safety data on at least 300 patients for 6 months and at least 100 patients for 12 months. Results of the TA-314 study are expected to be available by mid-2010.

"Initiation of the avanafil safety study is an important step in the development of the drug and demonstrates continued momentum at VIVUS," added Leland Wilson, president and chief executive officer of VIVUS. "We're very pleased with the progress we have made across our entire pipeline. We look forward to several significant milestones in the second half of this year, including results from two phase 3 obesity trials of our lead product Qnexa as well as data from the REVIVE trial of avanafil and participation in several upcoming medical meetings."


VIVUS is a biopharmaceutical company developing innovative, next-generation therapies to address unmet needs in obesity, diabetes and sexual health. The company's lead product in clinical development, Qnexa(TM), is expected to complete phase 3 clinical trials for the treatment of obesity in 2009. Qnexa is also in phase 2 clinical development for the treatment of type 2 diabetes. In the area of sexual health, VIVUS is in phase 3 development with avanafil, a potentially best-in-class PDE5 inhibitor, and in phase 2 development of Luramist(TM) for the treatment of hypoactive sexual desire disorder (HSDD) in women. MUSE(R) (alprostadil), a first generation therapy for the treatment of ED, is already on the market and generating revenue for VIVUS. For more information about the company, please visit

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimated" and "intend," among others. These forward-looking statements are based on VIVUS' current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; uncertainties of patent protection and litigation; uncertainties of government or third party payer reimbursement; reliance on sole source suppliers; limited sales and marketing efforts and dependence upon third parties; risks related to the development of innovative products; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that future clinical studies discussed in this press release will be completed or successful or that any product will receive regulatory approval for any indication or prove to be commercially successful. VIVUS does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in VIVUS' Form 10-K for the year ended December 31, 2008 and periodic reports filed with the Securities and Exchange Commission.


    VIVUS, Inc.                Investor Relations:  The Trout Group
    Timothy E. Morris                               Brian Korb
    Chief Financial Officer                         646-378-2923
                               Public Relations:    Pure Communications, Inc.
                                                    Sheryl Seapy

Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Results From Phase 3 EQUATE Trial of VIVUS Qnexa Highlighted at European Congress on Obesity
2. AcelRx Initiates a Phase 2 Study to Evaluate Functionality of Its ARX-01 Sufentanil NanoTab PCA System
3. BioMarin Initiates Phase 1/2 Clinical Trial for GALNS for Morquio A Syndrome
4. Dendreon Initiates Phase 1 Clinical Trial of Small Molecule Targeting TRPM8 in Cancer
5. VentiRx Pharmaceuticals Initiates Phase I Clinical Trial of VTX-1463, a Novel TLR8 Agonist for the Treatment of Allergic Rhinitis
6. Osprey Pharmaceuticals U.S.A., Inc. Initiates Phase Ib Clinical Trial in IgA Nephropathy
7. Pharmacyclics Initiates Phase 1 Clinical Trial of Novel Oral Btk Inhibitor for Refractory B-cell Non-Hodgkins Lymphoma
8. Pharmasset Initiates First Time in Human Study of PSI-7851 for the Treatment of Hepatitis C (HCV)
9. Radius Initiates Phase 2a Clinical Trial of RAD1901 in Menopausal Hot Flashes
10. Healthpoint Initiates Phase II, Dose-Finding Study to Evaluate Effectiveness of a Unique Cell Based Therapy in Venous Leg Ulcers
11. Aerovance Initiates Phase IIb Clinical Trial with Aerovant(TM) for the Treatment of Uncontrolled Asthma
Post Your Comments:
(Date:11/26/2015)... --> --> Juntendo University Hospital ... weighting of MRI for patients with Multiple Sclerosis (MS) ... with SyntheticMR in order to use SyMRI in clinical research ... generate multiple contrast images from a single scan and adjust ... it possible to both fine tune images and recreate additional ...
(Date:11/26/2015)... ) has ... Future Horizons and Growth Strategies in the ... Shares, Country Segment Forecasts, Competitive Intelligence, Emerging ... --> ) has announced the ... and Growth Strategies in the French Drugs ...
(Date:11/26/2015)... 26, 2015 Research and Markets ( ... Wound Care Market by Type (Dressings, Therapy Devices, Active ... Facility, Out-Patient Facility), and Geography - Global Forecast to ... --> --> The purpose of ... forecast of the global advanced wound care market. It ...
Breaking Medicine Technology:
(Date:11/25/2015)... ... 25, 2015 , ... Dr. John Pierce, Medical Director at the Ageless Forever ... with the Capillus272™ Pro laser therapy cap. FDA cleared for safety and efficacy, the ... the need for surgery, prescription pills, or topical foams. , “Capillus272™ Pro is ...
(Date:11/25/2015)... , ... November 25, 2015 , ... According to an ... robot is being more and more widely heralded as a breakthrough for performing hernia ... method has over traditional laparoscopic surgery is that it can greatly reduce the pain ...
(Date:11/25/2015)... ... November 25, 2015 , ... Wimbledon Health ... launches new Wimbledon Athletics Facebook page to educate the public, parents ... cardiac abnormalities. About 2,000 people under the age of 25 die from sudden ...
(Date:11/25/2015)... ... November 25, 2015 , ... SCOTTSDALE, ... facial plastic surgeon specializing in both surgical and non-surgical treatments, announced the expansion ... at Hobgood Facial Plastic Surgery. , Highly trained and nationally recognized for ...
(Date:11/25/2015)... ... November 25, 2015 , ... “While riding the bus, I saw a ... “I thought there had to be a convenient and comfortable way to protect them ... enables disabled individuals to safely travel during cold or inclement weather. In doing so, ...
Breaking Medicine News(10 mins):